Safety Observer 216
The FDA has published the final guidance on Neurodevelopmental Safety Studies in Neonates.
Report 216 — Highlights
FDA & Neonatal Safety
The FDA has published the final guidance entitled “Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development”.
EU Variation Regulation
Further to the publication of amendments to the Variation Regulation in June 2024, the CMDh and the EMA have published guidance to support variation applications implemented and submitted from 01-Jan-2025.
EMA: PhV Inspectors Report
The EMA has published the Annual Report of the Pharmacovigilance Inspectors Working Group for 2023, which provides an overview of inspections and findings in the period.
Ethiopia: New PV Guideline
The Ethiopian FDA has published a new version of its National Pharmacovigilance Guideline, which describes the obligations of MAHs.
Pakistan: e-submission of ICSRs
The Drug Regulatory Authority of Pakistan (DRAP) has announced the launch of an e-reporting System for ICSRs, which registration holders are required to use from 08-Nov-2024.
